The invention relates to orthotic devices and associated methods that assist with healing or correction of musculoskeletal defects or injuries.
The musculoskeletal system involves a network of ligaments, cartilage, muscle, bone and the like, which are generally controlled by the nervous system. The musculoskeletal system is subject to a variety of stresses, trauma and congenital defects. Surgery may be required to address certain problems, and physical therapy may solve other problems. In addition, a physician can use a variety of orthotic devices such as braces to stabilize an injured or diseased body part. The orthotic device may form an integral component of the treatment process.
The treatment process can involve a variety of stages that will strongly depend on the specific problem involved and on access to effective treatment methods. Exercise is a part of many treatment programs. It is known that properly designed exercise can increase the speed and improve the quality of the healing of many musculoskeletal injuries. But it is also recognized that inappropriate exercise can cause additional injury or slow healing.
Relatively sophisticated braces with built in transducers can be used to monitor an exercise program. The transducers measure the forces being exerted during an exercise routine. These braces serve a variety of purposes. An important purpose is to assist patients in monitoring their exercise while minimizing the risk of additional injury. Furthermore, these braces can assist the responsible physician to monitor efficiently the progress of the patient and to adjust the exercise program according to the progress or lack of progress by the patient.
Back problems are examples of musculoskeletal injury and are ubiquitous in our society. The spine has 24 motion segments. Forces and injury are concentrated at areas of transition between the spine""s most rigid and most flexible segments. This results in a tendency towards degenerative problems at the lower levels of the flexible elements of the lumbar and cervical spine. The spine involves an interrelationship of static soft tissue (e.g., ligaments and cartilage), muscle, flexible connective tissue (e.g., facet joints and disc spaces), bone, and nerve elements (including spinal cord, autonomic and radicular structure). This complex structure creates an enormously complex problem for the clinician attempting to assist a patient through a period of symptomatology.
Exercise is important for achieving and maintaining a healthy spine. Studies suggest that back muscles maintain the erect posture of the spine throughout the day. This requires a certain level of back muscle strength and endurance. This endurance is also necessary for lifting and load carrying. Therefore, specific and properly controlled exercises for back muscle strength and endurance may be useful in preventing or improving some lower back trouble.
In addition to problems of degeneration and weakness, misalignment of the spine can result in a variety of problems and can result in progressive degeneration. For example, adolescent idiopathic scoliosis affects approximately 1 to 3 percent of the juvenile population. The deformity appears during early adolescence as lateral curvature of the spine in either single curve or double curve patterns.
The most frequent locations of scoliosis are in the thoracic (chest area) and lumber (lower back region). A common pattern is the double xe2x80x9cthoracolumbar curvexe2x80x9d in which the spine resembles an xe2x80x9cSxe2x80x9d as the spine curves first one way in the chest area, then back the other way in the lower back. As the spine curves, it also rotates, producing either thoracic or lumbar prominences. Adolescent idiopathic scoliosis is a progressive disease, which often grows worse with the passage of time. The progression rate is significantly higher in young girls than in boys. Bracing can be successful in reducing or arresting progression.
Besides producing an undesirable appearance, spinal curvature can result in nerve compression as a result of impingement on nerve roots passing out from the spine to the limbs. In addition, spinal curvature can also result in reduced thoracic capacity including reduced cardiac and pulmonary function. These difficulties result from the size and shape of the chest. In extreme cases, premature death follows a lifetime of discomfort and deformity.
In certain circumstances, direct intervention to correct the curvature of the spine is indicated. Ultimately, about one youth in one thousand out of the general population is treated with bracing. Back braces, such as the Jewett brace, can be used to apply corrective forces to the spine.
The commitment to place an adolescent in a restricting device that encompasses the main trunk for long periods of time is a serious one due to the physical discomfort factors and the direct expense of fitting the brace and monitoring the disease through the treatment period. In spite of these deterrents, bracing is the most frequent treatment for adolescent idiopathic scoliosis because of the seriousness of the disease.
Surgery to fuse vertebrae in better positions is an alternative to bracing. Often in this surgery, rods are inserted along the side of the spine and tied to the vertebrae to hold the vertebrae in a better position. This surgery is a major and costly procedure and typically leads to lessened flexibility. Therefore, every effort is made to minimize the impact of the pathology and to avoid surgery, if possible. Alternatives to surgery include bracing for passive correction of the spinal deformity, and exercise for improved strength and control. Managed care providers often require bracing before surgery is attempted to correct or to stabilize spinal curvature.
The present invention involves a portable orthopedic restraining device for the passive correction of biological deformity and/or the exercising of muscles and other tissues associated with a joint or joints of a patient. In preferred embodiments the orthopedic restraining device includes bladders with pressure sensors. The bladders absorb some of the forces, and fluctuations in the bladder pressure provide for measurements of the forces applied by the patient. Bladders spread the forces over the patient""s skin and provide a direct measure of the forces on the skin to provide a warning if the pressures reach a level that would cause injury to the skin.
The invention includes corrective back orthoses. The corrective back orthoses provide for monitoring of the forces applied by the orthoses to permit more optimal use of the orthoses. In certain embodiments, bladders are used advantageously in the force applicators. The corrective back orthoses can include microprocessors for more sophisticated monitoring of compliance, variations in applied force and estimates of changes in the patient""s condition.
Specifically, in a first aspect, the invention involves an orthopedic restraining device including:
(a) a frame, which can restrain a first flexibly connected body portion of an individual relative to a second flexibly connected body portion;
(b) at least one bladder held by the frame, where the bladder contacts at least one of the flexibly connected body portions when the frame is restraining the flexibly connected body portions;
(c) a pressure sensor attached to the bladder such that pressure within the bladder is measured; and
(d) a microprocessor receiving the pressure measurements, where the microprocessor monitors variations in pressure and determines differences between the measured pressures and predetermined target values.
The frame can include a hinge or an articulating section. The bladder preferably is positionable relative to the frame to adjust the rest pressure within the bladder. The bladder preferably holds air. The first flexibly connected body portion of the individual and the second flexibly connected body portion can be connected by many types of joints such as hinge, ball and socket, intervertebral disc or synchondrosis. The orthopedic restraining device can further include a display for displaying a quantity related to the pressure.
In another aspect, the invention involves a corrective back orthosis including:
(a) a frame that fits around at least a portion of a patient""s torso to surround a portion of the patient""s spine;
(b) a bladder supported by the frame, where the bladder is positioned to provide corrective forces to the spine of the patient; and
(c) at least one pressure sensor attached to the bladder such that pressure within the bladder is measured.
The corrective back orthosis can further include a microprocessor, which monitors pressures measured by the sensor. The corrective back orthosis also can further include a graphic display interfaced to the microprocessor, where the graphic display depicts the forces along spinal orientations of the patient in order to permit adjustment of the forces through changes in pressure in the bladder. In addition, the corrective back orthosis can include a valve providing for the release of fluid from the bladder. The corrective back orthosis can include a plurality of bladders.
The corrective back orthosis preferably further includes a manual pump attached to the bladder such that activation of the manual pump adjusts pressure in the bladder by varying the amount of fluid within the bladder. The valve can be controlled by a microprocessor. The corrective forces applied by the corrective back orthosis preferably are oriented along a plurality of vectors. The corrective back orthosis can include a plurality of bladders with independently adjustable pressures.
In another aspect, the invention involves a corrective back orthosis including:
(a) a frame that fits around at least a portion of a patient""s torso to surround a portion of the patient""s spine;
(b) force applicators connected to the frame to apply force to the patient""s spine;
(c) a sensor that measures forces associated with the force applicators; and
(d) a control unit connected to the force sensor for displaying values related to the measured forces.
The control unit can include a microprocessor that monitors forces measured by the sensor. The corrective back orthosis can further include a graphic display interfaced to the microprocessor, where the graphic display depicts the forces along spinal orientations of the patient in order to permit adjustment of the forces. The corrective back orthosis also can further include strain gauges operably connected to the frame.
In another aspect, the invention involves a method of correcting spinal misalignment of a patient including the step of applying appropriate corrective forces to the spine using a back orthosis comprising at least one bladder and a pressure sensor positioned to measure pressure associated with the bladder, where the bladder is positioned to provide a contribution to the corrective forces and is adjusted to a desired inflation. The appropriate corrective forces preferably are oriented along a plurality of vectors. The back orthosis used in practicing the method can further include a microprocessor, which monitors pressures measured by the sensor and determines variation in the measured pressure and predetermined desired values. The microprocessor preferably is interfaced to a graphic display to provide a graphic analysis of the spinal deterioration and the vectors of the corrective forces used to correct the deterioration. The microprocessor can control a release valve to adjust pressure within the bladder. The method can further include the step of estimating using the microprocessor evolving force vectors based on estimated evolving conditions of the patient.
In another aspect the invention involves a method of correcting spinal misalignment including the step of applying appropriate corrective forces to the spine using a back orthosis comprising: a) force applicators connected to a frame that fits around at least a portion of a patient""s torso to surround a portion of the patient""s spine, b) a sensor that measures forces associated with the force applicators and c) a control unit that displays values related to the measured forces.